July 22, 2025

Why Pen Testing Matters for Digital Health products

By Craig Pepper · 2 minute read

For CTOs and compliance leads in digital health startups, cybersecurity can feel like a high-stakes tightrope walk. You’re building innovative health tech that handles sensitive patient data, all while navigating strict regulations and trying to earn the trust of hospitals, patients, and investors.

In this context, penetration testing isn’t just a technical exercise. It’s a critical part of ensuring your product is safe, your business is audit-ready, and your roadmap isn’t derailed by unseen vulnerabilities.

This blog explains why pen testing matters specifically for digital health products and how it supports your journey toward compliance and business success.

The High Stakes of Security in Digital Health

When lives and trust are on the line, startups in the health tech space face unique risks. One data breach, failed audit, or missed compliance deadline can derail product launches, investor confidence, or NHS onboarding.

In this environment, penetration testing serves as your proactive defence. Think of it as a professional “fire drill” for your system—spotting vulnerabilities before real attackers or regulators do.

What Is Penetration Testing?

Pen testing involves ethical hackers simulating real-world attacks on your application, APIs, cloud infrastructure, or connected devices. The goal is to identify and fix weaknesses before anyone else can exploit them.

Unlike automated tools, a pen test reveals logic flaws, misconfigurations, or overlooked risks—then gives you a report outlining what was found, why it matters, and how to fix it.

And it’s not a one-time event. Most digital health standards recommend or require pen testing at least annually, and also before major launches or integrations.

Five Reasons to Prioritise Pen Testing

1. Discover vulnerabilities before attackers do

Identify security issues early—before a breach, audit failure, or incident response effort forces your hand.

2. Prepare for audits and security reviews

Pen test reports are often requested by NHS trusts, ISO 27001 auditors, insurers, and procurement teams.

3. Support compliance with key regulations

Pen testing directly supports standards like:

ISO 27001 (A.12.6.1)
NHS DSPT and DTAC
GDPR (Article 32)
EU MDR (MDCG 2019-16)
Cyber Essentials Plus

4. Build trust with customers and partners

Buyers are more likely to trust a product that’s been tested and secured—especially in healthcare.

5. Prevent costly product delays

A failed security check can delay launches or derail onboarding. Regular pen tests avoid last-minute surprises.

What Happens If You Don’t Test?

Failed audits and lost contracts
Breaches that damage trust and attract fines
Delayed launches and lost revenue
Missed NHS integration due to unmet DTAC criteria
Reputational damage and investor concerns

Pen testing may feel like an overhead, but skipping it risks far more.

How Pen Testing Fits Into Your Roadmap

Make it routine

Include annual pen testing in your roadmap and run tests before major releases.

Link it to compliance

One test can help address multiple frameworks—ISO 27001, DSPT, Cyber Essentials, EU MDR.

Learn and improve

Use test results to guide fixes, train developers, and strengthen internal controls.

Partner with specialists

Work with a cybersecurity team that understands healthcare regulations and can guide your strategy end-to-end.

As a tech or compliance leader in digital health, your product must not only be innovative—but also secure and compliant. Pen testing is a practical step that protects your users, builds trust, and accelerates your path to market.